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Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

NCT06592924 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2026-04-14

No results posted yet for this study

Summary

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?

This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.

The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

Abiraterone

Assigned prior to enrollment

DRUG

Enzalutamide

Assigned prior to enrollment

DRUG

Apalutamide

Assigned prior to enrollment

DRUG

Darolutamide (BAY 1841788)

Assigned prior to enrollment

DRUG

Docetaxel

Assigned at enrollment

DRUG

ADT

Physician's choice. Assigned prior to enrollment

Sponsors & Collaborators

Principal Investigators

  • Michael Ong · Ottawa Hospital Research Institute, Ottawa ON Canada

  • Alexandra Sokolova · Oregon Health and Science University, Portland, OR, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2031-03-14
Completion
2031-04-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592924 on ClinicalTrials.gov